1. Field
This specification relates to cleaning and disinfecting devices, systems and methods for medical devices. More particularly, this specification relates to an integrated device that can be used to clean and disinfect both needle-free intravenous connectors (injection ports) and vascular access catheter hubs.
2. State of the Art
Needle-free intravenous ports and connectors were introduced in the late 1980's to reduce the incidence of accidental needlestick injuries that could lead to the transmission of AIDS and Hepatitis to healthcare providers. The intravenous ports and connectors are attached to vascular access catheters to provide the healthcare provider a means to intermittently infuse fluids to the patient and/or aspirate blood from the patient.
Since widespread use of needle-free intravenous connectors began in the early 1990's, a significant increase in intraluminal catheter-related bloodstream infections has occurred. This increase in the number of bloodstream infections has resulted largely from contamination of the IV ports and/or IV connectors by airborne sources and also by direct contamination of the components by the patient or healthcare provider. It has been estimated that this type of catheter-related bloodstream infection has resulted in excess of $25 billion in costs to healthcare facilities worldwide and up to a 25 percent mortality rate.
There is no widely accepted standardized procedure for cleaning and disinfecting intravenous needle-free connectors. Currently, medical practitioners use a 70% isopropyl alcohol pad for swabbing methods that typically involve the application of the disinfectant to the IV connector's surfaces. The current alcohol pads were not designed to clean and disinfect needleless IV connectors or ports. A proper cleaning procedure requires that both the septum and the proximal threaded portion of the needleless intravenous connector are properly cleaned and disinfected to ensure elimination of microorganisms in future uses. However, these swabbing methods are inevitably inconsistent because medical practitioners may inadvertently miss areas or fail to clean threaded areas of the IV connector effectively.
Another source of catheter-related bloodstream infections is the vascular access catheter hub. Needleless IV connectors are routinely changed approximately every 72-96 hours from the vascular access catheter due to infection concerns. When the needleless IV connector is changed and thrown away, the vascular access catheter hubs (1 to 5 hubs per catheter) must be cleaned and disinfected prior to placing new sterile needleless IV connector or connectors. The healthcare provider's hand contamination, particulate matter, blood, patient's skin flora, and other material can contaminate the catheter hub or the threads of the hub, and microorganisms can colonize thereon. Before accessing a catheter hub (e.g., on a central venous catheter line), hand hygiene should be performed, and the catheter hub should be cleaned and disinfected with a 70% isopropyl alcohol or povidone-iodine. Again, while medical practitioners are cautioned to clean the hub, the current cleaning procedures utilized (i.e. 70% isopropyl alcohol pads) are not designed to be used to clean and disinfect vascular access catheter hubs and are often inconsistent because medical practitioners may inadvertently miss areas or fail to clean the threaded area of the hub effectively.